Numed Multi-Track Angiographic Catheter Recall for Missing Instructions
Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because the Instructions for Use booklets were not included on the outer pouch.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to missing documentation (packaging-only problem) with no reported injuries or illnesses, fitting the Moderate criteria for minor labeling/packaging errors.
Plain-English summary
Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters (MMTA), Product Code MMTA05100. The recall is due to a packaging error where the Instructions for Use booklets were not included on the outer pouch.
The affected products are identified by Lot numbers 5MT-1264 and 5MT-1265, with an expiration date of September 30, 2023, and UDI 04046964312700. The distribution was limited to the state of Pennsylvania.
Healthcare providers should stop using the affected units and contact Numed Inc for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel
- Manufacturer
- Numed Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot numbers: 5MT-1264
- 5MT-1265 Exp. Date: 2023-09-30 UDI: 04046964312700
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Numed Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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